Vitassay Calprotectin Turbidimetric Assay
Ref 7115002
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-ESMF0000309597115002GX D-ESMF0000309597115002GX | Date1 Oct 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- Calprotectin Turbidimetric Assay
- Model / Reference
- 7115002
- Primary DI / UDI-DI
- D-ESMF0000309597115002GX
- Basic UDI-DI
- B-ESMF0000309597115002GX
- EMDN Code
- W0102019009 Calprotectin
- Device Class
- Class IVD General
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- ES-MF-000030959
Other devices from Vitassay Healthcare S.L.U
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No